MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON 5 PRO; OVDS

Model Number	TV60ML
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an explantable device.(b)(4).Device evaluation: product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed and no deviation related to current complaint is reported in the manufacturing record.The product was manufactured and released according to specifications.A search in complaint system revealed that there was 1 other complaint related to the reported issue.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.
Event or Problem Description
It was reported that the healon product coagulated in the left eye of a patient and they could not get it out.The doctor had to use interior vitrector to remove the material from the eye.Even with high vacuum it occluded the handpiece.They had to make an enlarged incision and use sutures on the patient.The doctor thinks that he took care of the issue and no surgical or medical interventions are required in the future.It was indicated that the patient seemed to be fine and there was no apparent adverse affects.The patient was sent home directedly after the surgery.The account reported the syringe was thrown away.No additional information was provided.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: HEALON 5 PRO
• Common Device Name: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10248308
• Report Number: 3004750704-2020-00032
• Device Sequence Number: 13587187
• Product Code: LZP
• UDI-Device Identifier: 05050474636996
• UDI-Public: (01)05050474636996(17)221130(10)UE31773
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P810031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: TV60ML
• Device Catalogue Number: 10240015
• Device Lot Number: UE31773
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005